MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number PS10.0-65D250

Device Problem Material Erosion (1214)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information has been provided, a supplemental report will be submitted.

Event Description

Information was received that the patient experienced pain at the junction of the nail.Upon removal, it was noted that there was rust at the junction and a huge callus formation.

Event Description

No additional information was provided.

Manufacturer Narrative

The nail was returned for visual and functional testing.Visual inspection revealed that the device had corrosion on the junction of the distraction rod.Functional testing was not applicable due to the reported failure mode.Device history review: a device history review (dhr) was performed on lot number: 9051314 and there were no deviations in the manufacturing process and the finished product met all acceptance criteria prior to shipment.

• Brand Name: PRECICE STRYDE SYSTEM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr, suite 100; aliso viejo CA 92656
• MDR Report Key: 11922080
• MDR Text Key: 253787045
• Report Number: 3006179046-2021-00288
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00887517951175
• UDI-Public: 887517951175
• Combination Product (y/n): N
• PMA/PMN Number: K180503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS10.0-65D250
• Device Lot Number: 9051314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 60